Sanitary control and risk assessment of blood establishments in amazonas, the largest state in the brazilian amazon (2023-2025)
1
Departamento de Vigilância Sanitária, Secretaria Municipal de Saúde de Manaus, MANAUS, Brazil
2
Departamento de Vigilância Sanitária, Fundação de Vigilância em Saúde do Amazonas - Dra. Rosemary Costa Pinto, MANAUS, Brazil
3
Gerência de Sangue, Tecidos, Células, Órgãos e Produtos de Terapias Avançadas (GSTCO), Agência Nacional de Vigilância Sanitária, Brasília, Brazil
4
Diretoria da Presidência, Fundação de Vigilância em Saúde do Amazonas - Dra. Rosemary Costa Pinto, MANAUS, Brazil
5
OPAS BRASIL, Organização Pan-Americana da Saúde (OPAS), Brasilia, Brazil
6
Subsecretaria de Vigilância Sanitária, Secretaria Municipal de Saúde de Manaus, MANAUS, Brazil
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
BACKGROUND:
The state of Amazonas (AM) faces logistical challenges due to the large extension of rain forest, limited road network and population of over 4 million inhabitants. Transportation occurs primarily by river and occasionally by aircraft. Within this context, the competent authorities of National Health Regulatory System (SNVS) - ANVISA (national), DEVISA/FVS-RCP (state), and VISA MANAUS (municipality) – inspect Blood Establisments (BEs) to monitor Good Practices. Historically, BEs in AM have been marked by significant non-conformities, with most services classified as High Potential Risk (HPR) according to the Potential Risk Assessment Methodology for Blood Establishments (MARP-SH). Therefore, SNVS intensified BEs inspections, mapping risks and identifying opportunities for improvement through inter-institutional actions.
METHODS:
MARP-SH has been systematically applied by competent authorities in regulatory inspections, allowing classification of BEs into categories, ranging from Low to HPR. Results have been discussed among competent authorities and stakeholders to enforce corrective actions and stimulate improvement measures, considering risk-benefits and access to blood componentes.
RESULTS:
Between 2023 and 2025, 74 BEs (85%) were inspected, a substantial increase compared to 32 (37%) in 2020–2022. Expanded regulatory coverage led to a qualitative reduction in sanitary risk, reflected in improved compliance with Good Practices and reclassification of all private BEs out of HPR category. Public BEs remain a challenge, due to structural constraints typical of remote and resource-limited settings. Inter-institutional collaboration strengthened regulatory oversight, enabling increased public investment and targeted training to address non-conformities.
CONCLUSIONS:
From 2023 to 2025, SNVS more than doubled inspection coverage (85%) compared with 2020–2022 (37%), despite the historic droughts of 2023-2024 linked to climate change. Coordinated actions among SNVS authorities expanded regulatory oversight and strengthened risk reduction and quality in BEs. This experience shows that risk-based, coordinated sanitary control models can be applied in geographically challenging settings and transferred to other remote regions.
The state of Amazonas (AM) faces logistical challenges due to the large extension of rain forest, limited road network and population of over 4 million inhabitants. Transportation occurs primarily by river and occasionally by aircraft. Within this context, the competent authorities of National Health Regulatory System (SNVS) - ANVISA (national), DEVISA/FVS-RCP (state), and VISA MANAUS (municipality) – inspect Blood Establisments (BEs) to monitor Good Practices. Historically, BEs in AM have been marked by significant non-conformities, with most services classified as High Potential Risk (HPR) according to the Potential Risk Assessment Methodology for Blood Establishments (MARP-SH). Therefore, SNVS intensified BEs inspections, mapping risks and identifying opportunities for improvement through inter-institutional actions.
METHODS:
MARP-SH has been systematically applied by competent authorities in regulatory inspections, allowing classification of BEs into categories, ranging from Low to HPR. Results have been discussed among competent authorities and stakeholders to enforce corrective actions and stimulate improvement measures, considering risk-benefits and access to blood componentes.
RESULTS:
Between 2023 and 2025, 74 BEs (85%) were inspected, a substantial increase compared to 32 (37%) in 2020–2022. Expanded regulatory coverage led to a qualitative reduction in sanitary risk, reflected in improved compliance with Good Practices and reclassification of all private BEs out of HPR category. Public BEs remain a challenge, due to structural constraints typical of remote and resource-limited settings. Inter-institutional collaboration strengthened regulatory oversight, enabling increased public investment and targeted training to address non-conformities.
CONCLUSIONS:
From 2023 to 2025, SNVS more than doubled inspection coverage (85%) compared with 2020–2022 (37%), despite the historic droughts of 2023-2024 linked to climate change. Coordinated actions among SNVS authorities expanded regulatory oversight and strengthened risk reduction and quality in BEs. This experience shows that risk-based, coordinated sanitary control models can be applied in geographically challenging settings and transferred to other remote regions.
| eISSN: | 2654-1459 |
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